Melag MelaTronic 17, MelaTronic 23 User manual

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The functional effectiveness and the preservation of the
Operating Manual
For the MELAG Autoclaves
MELAtronic®17
®
23
Dear Doctor:
Thank you very much for the trust that you have shown in our products by purchasing this auto­clave.
For 50 years now, MELAG — a medium-sized, family owned and operated business — has specialized in the production of sterilization equipment for medical practice. During this period, MELAG has succeeded in becoming a leading manufacturer of sterilization equipment. More than 335,000 MELAG units sold throughout the world testify to the exceptional quality of our sterilization systems — which are manufactured exclusively in Germany.
As all other MELAG products, this autoclave was manufactured and tested according to strict quality criteria. Before placing this unit into operation, please carefully read this Installation and Operating Manual. Also please carefully read the section on the proper preparation of instru­ments for sterilization. The long-term functional effectiveness and the preservation of the value of your autoclave will primarily depend on careful regular maintenance of this unit.
The staff and management of MELAG
We reserve the right to make technical modifications without prior notice
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value of this equipment will depend on:
The proper preparation of the objects that you wish to sterilize
The prevention of rust being introduced to the system from the
outside
The careful care of the equipment
The regular exchange of distilled or demineralized water.
Page
1 INTRODUCTION........................................................................................................................................ 2
1.1 ELEMENTS ON THE FRONT OF THE AUTOCLAVE ........................................................................................ 3
1.2 TECHNICAL DATA................................................................................................................................... 3
1.3 PREPARATION OF INSTRUMENTS.............................................................................................................4
1.4 RUST IN THE AUTOCLAVE: BROUGHT IN FROM THE OUTSIDE ..................................................................... 4
1.5 CARE OF THE AUTOCLAVE ...................................................................................................................... 4
1.6 INSTRUCTIONS FOR CHECKING AND CARING FOR THE DOOR AND DOOR-LOCK COMPONENTS....................... 5
1.7 FUNCTIONAL TESTING OF THE AUTOCLAVE ..............................................................................................6
2 PLACING THE AUTOCLAVE INTO OPERATION ................................................................................... 6
2.1 SETTING UP THE AUTOCLAVE ................................................................................................................. 6
2.2 FILLING THE WATER STORAGE TANK........................................................................................................7
2.3 VDE REGULATIONS ...............................................................................................................................7
3 INFORMATION FOR EVERY STERILIZATION CYCLE...........................................................................7
3.1 OBJECTS BEING STERILIZED ................................................................................................................... 7
3.2 THE STERILIZATION SEQUENCE...............................................................................................................8
3.3 CHECKING TO ENSURE THAT THE CYCLE HAS PROPERLY RUN ................................................................... 8
3.4 ABORTING THE PROGRAM ...................................................................................................................... 9
3.5 REMOVAL OF DRY OBJECTS READY TO USE ............................................................................................. 9
3.6 FREQUENCY OF DAILY STERILIZATION ..................................................................................................... 9
4 ADDITIONAL INFORMATION ON STERILIZATION ................................................................................ 9
4.1 TOTAL OPERATING TIME (STERILIZATION CYCLE TIME) .............................................................................. 9
4.2 USING DISTILLED OR DEMINERALIZED WATER......................................................................................... 10
5 TROUBLESHOOTING.............................................................................................................................11
5.1 TROUBLE WITHOUT AN ERROR REPORT ................................................................................................. 11
5.2 MALFUNCTIONS WITH ERROR MESSAGES ..............................................................................................12
6 SAFETY INSTRUCTIONS / WARNINGS................................................................................................13
7 PLACING THE AUTOCLAVE OUT OF OPERATION / TRANSPORT INSTRUCTIONS / PLACING THE
AUTOCLAVE BACK INTO OPERATION ............................................................................................... 14
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8 ANNEX / SPARE PARTS ........................................................................................................................ 15
8.1 SPARE PARTS .....................................................................................................................................15
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Operating Manual for MELAtronic®17/23
1 Introduction
1.1 Elements on the front of the autoclave______________________________________
1 Enclosure lid 6 Switch for water feed 12 Lamp for “Heater is on”
7 Power switch 13 Lamp for “Cycle is running” 2 Grating rack to hold the
trays, etc. 3 Pressure gauge 9 Button to turn drying on 15 Adjustable feet of the unit 4 Switch for program selection 5 Switch to start program
8 Display 14 Opening to check for water filling
10 Button to turn drying off 16 Drain for distilled water 11 Show remaining run time /
cancel error message
1.2 Technical data _______________________________________________________
MELAtronic®17 MELAtronic®23
Chamber dimensions ( diam. ! depth ) 18 ! 42 cm 23 ! 45 cm Loading capacity (incl. trays):
Instruments 3 kg 4 kg Textiles 200 g Unwrapped,
or wrapped in paper: 500 g
In sterilization container: 300 g Amount of water required per sterilization cycle 350 ml 400 ml Parameters for Program 1 (121°C) 121°C, 1 bar, 25 min sterilization time Parameters for Program 2 (134°C) 134°C, 2 bar, 5 min sterilization time Overall cycle time: Program 1 40 minutes 45 minutes Program 2 25 minutes 30 minutes Drying time Can be selected as required Waiting time between sterilization cycles: 15 minutes 15 minutes Electrical ratings: AC
Backup fuses (2 for each unit)
230 V / 1350 W
16 A FF
Model for 230 V / 1970 W Model for 110 V / 1600 W Model for 230 V: 16 A FF Model for 110 V: 20 A FF
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1.3 Preparation of instruments _______________________________________________
MELAG non-rusting materials
All parts of MELAG autoclaves that come into con­tact with steam are made of non-rusting materials. The sterilization chamber, the water tank, and the tray rack are made of stainless steel. The steam lines are of copper; the sterilization-chamber door, of chrome-plated brass; and the trays, of anodised aluminium.
Rust dragged in from the outside
The use of these materials means that the autoclave itself cannot produce rust. When rust does attack the autoclave or sterilized objects, investigations have always consistently that this rust is dragged in by instruments when they enter the autoclave. It must be remembered that even stainless-steel instru­ments from leading manufacturers can develop rust: for example, after improper treatment with chemical cleaning and disinfecting agents during instrument preparation.
Preparation of the objects to be sterilized
The problem of rust dragged in from the outside shows how important it is to properly prepare the objects to be sterilized. The following preparation instructions are absolutely essential to ensure proper sterilization: After instruments are used, they must immediately
be disinfected and cleaned in a disinfection and/or cleaning agent, according to UVV/VBG 103. Be sure to use the correct dosage of the agents, and to leave the instruments in the solution for the pre­scribed length of time. We also recommend using such aids as ultrasonic devices and thermal disinfec­tors.
Important: It is essential that the instruments be properly cleaned before disinfection, to avoid debris separating from the instruments under steam pres­sure and clogging the nozzles and valves of the autoclave. Latches, catches, joints, and hinges must especially be cleaned very thoroughly with a brush. Completely rinse off cleaning and disinfect­ing agents under running water, while using a brush before putting the instruments into the autoclave. Warning: Do not by any means allow any residue of chemical substances from cleaning and disinfect­ing agents to enter the autoclave, since they will cause corrosion. As last step, finally rinse the in­struments with demineralized water, dry them care­fully, and place them into the autoclave.
New instruments being sterilized for the first time
The above-described cleaning procedure must also be used for brand-new instruments, since they often carry small amounts of oil, grease, and debris from their production processes.
,
1.4 Rust in the autoclave: brought in from the outside ___________________________
As described above, this autoclave itself cannot rust owing to the kind of materials of which it is made. Any rusty spots in the autoclave are “dragged-in rust”: from instruments or other metal objects with rusty spots. This can occur on standard steel whose electroplating is damaged, or even on stainless-steel objects. Often, only one single rust-emitting instru­ment is enough to cause rust to develop on other instruments or in the autoclave. Dragged-in rust will then transfer to other instruments or parts of the autoclave, and will spread from there. This is why
the sterilization chamber must be regularly wiped out to prevent dragged-in rust from remaining on the surface and further developing. Dragged-in rust must be removed from the sterilization chamber, the water tank, and from the tray rack. We recommend using stainless-steel cleansers such as product Si­dol or an equivalent. Warning: Do not use steel wool or steel brushes. To clean the sterilization chamber, first pull the tray rack out of the chamber.
Important: Do not sterilize rusty instruments.
1.5 Care of the autoclave ____________________________________________________
Required each week
Cleaning of the sterilization chamber You must clean the sterilization chamber and the
door seal on the chamber at least once a week. First take out the trays, and then pull the tray rack out of the chamber. Wipe out the chamber with a soft cloth or sponge. For stubborn stains, use stain­less-steel cleaner such as Sidol. Caution: Make sure not to let such cleaning agent enter the piping that leads out of the sterilization chamber. Also wipe only in the direction of the surface structure. Do not use steel brushes or pot cleaners made of metal. The cleaning agents must not contain chlorine, and must not be alkaline. You can remove spots from stainless steel by using a 5% solution of oxalic acid.
Door seal Check the door seal once a week for damage. Clean
the seal with normal, commercially available liquid cleansers.
Every two weeks
The water tank (for distilled or demineralized water) Every two weeks, drain the distilled or demineralized
water from the tank by opening the drain cock (16). Clean the water tank if necessary: for example, with a bottle brush, warm water, and a grease-cutting agent. Rinse out with water and fill with fresh dis­tilled or demineralized water (see Section 4.2 for water quality).
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Operating Manual for MELAtronic®17/23
1.6 Instructions for checking and caring for the door and door-lock components _____
In order to prevent premature wear, the threaded spindle of the palm grip hand knob, as well as the hinges of the latch yoke and the door locking bar, must always be kept well greased. We recommend plain-bearing grease (MELAG article no. 24355), silicone grease, or Molykote.
The following drawings indicate trouble that may occur and that may be the result of excessive wear on the door locking system. If any of these difficulties occur, inspection will be necessary by a MELAG Customer Service representative, or by an authorized technician from a specialist dealer.
Excessive play in the hinge of the pressure locking bar (the door “hangs”)
Important: The hinge bolts must by all means remain inserted completely in the latch and in the hinge yoke of the pressure locking bar (left side). The bolt must be flush as shown.
Excessive play in the hinge of the latch yoke
Hard-metal screw-thread insert has been screwed out of the latch.
If this bolt moves up or downward and is no longer flush with the yoke (as shown in proper position in left drawing), do not use the autoclave. It must be repaired by Technical Customer Service personnel.
Excessive play in the threaded spindle of the palm grip hand knob (rattling of the spindle in the latch)
Definite difficulty in turn-
ing the threaded spindle
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1.7 Functional testing of the autoclave_________________________________________
Regular checks
The microprocessor control for the MELAtronic automatically monitors sterilization temperature and time. You can check the pressure gauge during ster­ilization (white pointer). After sterilization, the red non-return (slave) pointer will show the maximum pressure reached. If there is no error message in the display at the end of the program, and return pointer is between 1 and 1.3 bar for Program 1 (121°C) or between 2 and 2.4 bar for Program 2 (134°C), and correctly observed (see Sections 3.1 and 3.2), then you can assume that effective sterilization has taken place.
Periodic checks (every six months)
German standard DIN 58 946, Part 8, Section 3.2, recommends: “Period testing should take place at the site of use, at recommended intervals of six (6) months. The purpose of testing is to verify that the small-size sterilizer effectively sterilizes upon observance of operating instructions.” Hygiene institutes and state medical laboratories will provide test spores upon request. They analyse these spores and provide test results on a test form. DIN 58 946, Part 4 and DAB 10 (official German Pharmacopoeia), stipulate that Bacillus Stearother- mophilus spores (for example, the product ATCC 7953, Paper Spore Strips, supplied by the company Oxoid, Cd. number BR 23), must be used to test steam autoclaves. As stipulated, five bioindicators (plus a positive sam­ple) are necessary to test the MELAtronic (chamber volume > 5 dm!), in accordance with
if the loading instructions have been
if the red non-
®
17/23
DIN 58 946, part 8. If the test spores already are already packed example, spore strips in paper packs, test tubes, or the product Attest), do not pack them again in additional enclosures when you place them in the autoclave. When conducting a spore test, the most stringent sterility precautions are necessary to prevent re­contamination. For example, after sterilization do not pack the spore packets into the same envelopes used to send them to you. Also do not use the same tweezers after testing as before. We recommend sterilizing the tweezers along with the test spores. To avoid falsifying your results in making your an­alysis, do not allow the non-sterilized positive sam­ple to come into contact with the sterilized test spores. For transport purposes, you can also submit your positive sample in a paper package that you have also sterilized.
Important note:
If the test spores are in a tube that is perforated only on one side (for example, the product Attest by 3M), then observe the following:
Never place these tubes into the autoclave with the perforation pointing upward (with Attest, the perfora­tion is in the brown closure cap). Since this auto­clave functions by the gravitation principle, the perfo­ration should ideally point downward: but at least toward the side (as is the case for tubes).
If you are using “handmade” test-spore products that are directly sealed in a paper-film package, then ensure that the paper sides are freely exposed to the steam. The paper sides of the package should likewise point to the side or downward.
(for
2 Placing the autoclave into operation
2.1 Setting up the autoclave _________________________________________________
Electrical connection
The autoclave must be powered from a separate circuit. This circuit must be additionally protected by a quick circuit breaker.
Open intervals to the sides
The autoclave must be set up with an open interval of at least 10 cm from the nearest walls. The open space above the autoclave should be at least 30 cm. It is very important for proper sterilization that the autoclave be correctly set up. The following instruc­tions must therefore be very carefully followed: both for the first installation, as well as for any change in location.
Correct: setting up on a perfectly level surface
This MELAG autoclave uses its own, direct supply of water. This convenience makes it very important that the autoclave operate on a perfectly level surface. The sterilization chamber is installed inside the auto­clave at a certain angle of slope to the rear, which means that the distilled or demineralized water be­comes visible through the opening to check for filled
for filled water (14) only after the required amount of water has flowed into the chamber.
Incorrect: setting up on a surface sloping to­ward the front of the autoclave
If you try to install this autoclave on a surface that slopes to the front of the autoclave demineralized water will already become visible at the front of the sterilization chamber, through the opening to check for water filling (14), before water has flowed in. This means that there will not be enough distilled or demineralized water to achieve the proper pressure of 2 bar in the chamber, and for this pressure to be maintained approx. 5 min. – or that a pressure of 1 bar cannot be main­tained constant for the required time of action of 20 min.
Incorrect: setting up on a surface sloping to­ward the rear of the autoclave
If you try to install this autoclave on a surface that slopes toward the rear of the autoclave or demineralized water will become visible at the
, the distilled or
enough
, the distilled
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Operating Manual for MELAtronic®17/23
front of the sterilization chamber, through the open­ing to check for water filling (14), after
too much water has flowed in. The excess water not con­sumed during sterilization will then remain in the chamber (which, however, will not impair autoclave functions).
Adjusting the level of the autoclave
To make sure that the autoclave has been installed on a perfectly level surface, it is delivered with a
graduated test cup. To make this adjustment, fill 350 ml of distilled or demineralized water from the cup into the front of the sterilization chamber of the MELAtronic
tronic
®
®
17 (or 400 ml of water for the MELA-
23). The autoclave is perfectly level if the filled water is visible at the opening to check for filled water (14) of the tray rack. If the autoclave is not level, adjust it by turning the front feet (15) up or down.
2.2 Filling the water storage tank _____________________________________________
Take off the enclosure lid (1) on the housing of the autoclave, and then remove the cover of the water storage tank.
Fill the water tank with approx. 3 litres of distilled or demineralized water. Do not fill above the line marked “MAX”. Make sure that the cooling coils in the water storage tank are always covered with
condense, will prevent unpleasant steam effects, and will reduce the consumption of distilled or de­mineralized water. For this reason, always keep the level of water filled above the coils. Or, better, drain off the remaining water through the drain for distilled water (16), and then fill up to the “MAX” level with distilled or demineralized water.
water. This will allow the outstreaming steam to con-
2.3 VDE regulations ________________________________________________________
According to the presently valid VDE regulations (Society of German Electrical Engineers), these autoclaves may not
be operated in areas subject to
explosion hazards.
These autoclaves may be repaired only by the manufacturer or by personnel expressly authorized
by the manufacturer (specialist dealers or Customer Service).
DANGER ! The edge of the door, the edge of the sterilization chamber, and the sterilized objects become very
hot during operation.
3 Information for every sterilization cycle
3.1 Objects being sterilized __________________________________________________
®
Tray racks must be used
To prevent the danger of overheating of the sterilized items by the heat radiated from the sterilization chamber, these autoclaves must not be operated without using a closed MELAG tray rack. These trays, other supports on which the sterilized items are placed, and containers for these items (with or without covers) must be perforated.
Sterilization packages
The items for sterilization can also be sterilized in sealed see-through sterilization packaging: for ex­ample, MELAfol
®
(with one side paper and one side transparent film). During sterilization, the paper side of the packs must face downward must not
be placed on top of each other on a tray.
. These packs
For better drying, we recommend lining up the see­through sterilization packs vertically, like cards in a card-file box: for example, in a MELAG Package Holder (MELAG article no. 283; this product fits
only in the MELAtronic
®
23). When sealing the
sterilized items in a package, make sure that the sealing seams are at least 8 mm wide (as stipulated
by DIN 58953). The MELAG MELAseal Package Sealing Devices produce a sealing seam 10 mm wide.
Sterilized items that are sensitive to heat IMPORTANT: When sterilizing plastic articles,
make sure not to exceed the maximum steriliza­tion temperature as given by the manufacturer.
By no means allow heat-sensitive products (such as dental aspirator tubes) to come into direct contact with the tray rack of the autoclave. The rack be­comes very hot from the heat radiated from the ster­ilization, and this can damage such sensitive items.
Always place plastic articles (such as aspirator tubes) on the middle tray. We recommend not plac­ing heat-sensitive items directly onto the autoclave tray, but on a sheet of filter paper.
Liquids Warning: These autoclaves are not suited for the
sterilization of liquids.
100/101
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3.2 The sterilization sequence ________________________________________________
1. Switch on the power switch
Switch on the autoclave by the power switch (7). The autoclave will then test the electronic sys­tems and will display the interior temperature of the sterilization chamber.
2. Reset the red non-return (slave) pointer
Set the red non-return (slave) pointer of the pres­sure gauge (3) to “0”.
3. Load the autoclave
Loosely load the trays or the sterilization contain­ers with the objects to be sterilized, and slide in. “Loosely” means the following, for example: do not load textiles that are tightly folded, and do not tightly press them into the sterilization containers. Do not load more items than allowed (see Tech­nical Data for limits).
4. Select the sterilization program
Use the switch for program selection (4) to choose the desired program. Use Program 1 to sterilize heat-sensitive objects (of rubber, textiles, etc.) at 121°C. Use Program 1 to sterilize bulky instruments (of metal, glass, etc.) 134°C.
5. Fill the water
Set the switch for water feed (6) to “I” (green lamp now shows) and wait until the water be­comes visible at the opening to check for filled water (14). When it becomes visible, set switch (6) to “0”.
6. Close the door
Close the door. Swivel the latch over the door locking bar, and lock the door by tightly screwing down the palm grip hand knob.
7. Start the program
Start the program by pressing the Start button (5). The display (9) will briefly confirm the pro­gram start by showing “Run”. The lamp for “Cycle is running” (13) and the lamp for “Heater is on” (12) will show at the same time.
8. Program run
The program will now run fully automatically. The display will continuously show the steam tem­perature in the sterilization chamber. After the air­removal phase (approx. 15 min; temperature ap­prox. 100°C), the heating-up time will follow. The pressure and temperature will rise to the param­eters required by the specific program. When the minimum temperature is reached (121°C for Pro­gram 1 and 134 °C for Program 2), the actual sterilization phase will begin. The sterilization time will now begin to run: 20 min for Program 1, and 5 min for Program 2. To find out how much time remains in the current sterilization run, press the time button (11). During the sterilization period, the autoclave con­trol system will maintain the sterilization tempera­ture for Program 1 at 122°C and for Program 2 at 136°C.
9. End of the sterilization cycle
At the end of the sterilization cycle, quick pres­sure release will automatically take place. The lamps for “Heater is on” (12) and “Cycle is run­ning” (13) will go out.
10. Open the door
Check the pressure gauge to make sure that the pressure has been completely released. Then you can safely open the door.
11. Drying and removing the sterilized objects
If the sterilized objects are wrapped, you must leave the autoclave door slightly open for a few additional minutes to allow sufficient drying. In addition, you can also activate the drying function by pressing button “ “ (also see Section 3.5). Af­ter the objects have dried, you can remove them from the autoclave and switch off the heating by pressing button “ “.
Warning: The sterilization compartment, the door, and the sterilized objects are very hot. You must use the MELAG Tray Handle to remove the objects, or you must wear heat-protection gloves during this operation.
3.3 Checking to ensure that the cycle has properly run ___________________________
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If there is no error message on the display at the end of the program, and between 1 and 1.3 bar for Program 1 (121°C) or
if the non-return pointer is
between 2 and 2.4 bar for Program 2 (134°C), then the program cycle has correctly run.
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Operating Manual for MELAtronic®17/23
3.4 Aborting the program ____________________________________________________
You can abort (terminate) the program at any time. Proceed as follows:
1. Push both of the following buttons, below the
display, at the same time: the button to turn the drying function off (10), and the time button (Show remaining run time, button [11]). The fol­lowing error message will appear on the display:
“Err2”. At the same time, the quick pressure re­lease procedure will automatically take place.
2. Observe the pressure gauge until the pressure falls to “0”.
3. Acknowledge the error message by pressing the time button (11).
4. You can now open the autoclave door.
3.5 Removal of dry objects ready to use _______________________________________
Observe the following steps to ensure obtaining dry, sterilized objects ready to use from the autoclave:
1. Wait until the quick pressure release has auto­matically taken place, and the reading on the pressure gauge has fallen to “0”.
2. Open the door of the autoclave slightly and leave it ajar.
3. Press the button “ “ to turn on the drying func­tion. The display will now show “Dry”, alternating with the interior temperature of the sterilization chamber.
4. Wait until the sterilized objects are as dry as you require.
5. End the drying function by pressing the button “ “.
Filter paper
Experience has shown that optimal results are ob­tained by placing a sheet of filter paper on the tray, then the objects to be sterilized, then on top of the objects a second sheet of paper.
Do not use gauze or other types of cellulose for this purpose
Do not use saturated cellulose products or gauze instead of filter paper as described above. The steam of the autoclave can dissolve substances in cellulose and gauze that will deposit in the form of spots on the sterilized objects.
3.6 Frequency of daily sterilization ____________________________________________
You can use MELAG autoclaves to sterilize up to approx. eight (8) cycles per day. This large number of sterilization cycles is made possible by the MELAG system, which evaporates and re­condenses only a relatively small amount of distilled or demineralized water per sterilization cycle.
Waiting period between sterilization cycles
When a sterilization cycle finishes, a waiting period of at least fifteen (15) minutes must be observed between the end of the one program and the begin­ning of the next.
4 Additional information on sterilization
4.1 Total operating time (sterilization cycle time) ________________________________
Operating times:
Program 1 (1 bar at 121°C): 35 … 45 min
Program 2 ( 2 bar at 134°C): 20 ... 30 min
When you begin the program with the “Start” button (5), the program will begin and run fully automati­cally. The actual sterilization time itself will begin to run only when the respectively required sterilization temperature has been reached. Since the air-re­moval time and the heating-up time until reaching of the required sterilization temperature will depend on the loading of the autoclave, and on the temperature of the sterilization chamber when the cycle starts, the total operating time is not fixed and will vary within the two ranges given above.
Times included in the total operating time
The total operating time (i.e., the overall time, or cycle time) includes the individual time sequences
such as heating-up time, ventilation time, tempera­ture-rise time and equilibration time, and the sterili­zation time. Sterilization time consists of the kill time and the safety-margin period.
Drying time and drying temperature Drying time: as desired Drying temperature:
Mantle of sterilization chamber: approx. 120°C
Interior of sterilization chamber: approx. 60°C
The mantle of the sterilization chamber is kept con­stantly at 120°C during the drying period. When the heating system is on, “Dry” will appear on the dis­play, alternating with the interior temperature of the sterilization chamber. You can deactivate the drying function by pressing the button to turn it off (10).
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"
µ
4.2 Using distilled or demineralized water ______________________________________
Water quality requirements
For steam sterilization, it is necessary to use steam­distilled water (aqua dest) or fully demineralized water (aqua dem).
Please observe the following guideline data for the quality of the water that you use; this data is in ac­cordance with the CEN standard DIN EN 285:
"
Conductivity
Evaporation residue
Silicon and SiO2
Iron
Cadmium
Lead
Heavy metals, except for the above
Chlorides
Phosphates
pH value 5 ... 7
Water colour Colourless, clear,
Hardness
Important note:
The use of feed water with constituents at greater
concentrations than those given above can greatly
shorten the service life of an autoclave, and can
nullify the manufacturer’s guarantee.
*) µS/cm = microsiemens per centimetre
15
"
10 mg/l
"
1 mg/l
"
0.2 mg/l
"
0.005 mg/l
"
0.05 mg/l
"
0.1 mg/l
"
2 mg/l
"
0.5 mg/l
without residue
"
0.02 mmol/l
S/cm*)
µ
For operation of the MELAtronic
fully demineralized water in accordance with VDE 510 is also sufficient, if this water meets VDE
regulations (i.e., conductivity after water treatment " 10 µS/cm*); conductivity upon use " 30 µS/cm*; pH value as set forth in DIN EN 285; evaporation resi­dues similar to those set forth in DIN EN 285).
Sources of water
Demineralized water is available on the commercial market in accordance with VDE 510. The label of the purchased container must specifically verify that the water meets classification specifications as set forth in VDE 510.
Poor water can damage the autoclave
If poor-quality water is used, scale deposits (calcium carbonate, CaCO and the vent nozzle can impair the functions of the autoclave.
Formation of spots
The extent of spots produced on sterilized instru­ments will depend on the quality of the water used to produce the steam. For steam sterilization, it is ne­cessary to use steam-distilled water (aqua dest) or fully demineralized water (aqua dem).
) in the steam lines, the valves,
3
®
17/23 autoclaves,
4.2.1 Amount of water consumed _____________________________________________
After each sterilization cycle, the water in the auto­clave storage tank will be reduced by the amount of steam that does not completely condense. The ex­act amount of losses will depend on a number of circumstances:
Factor: time interval between sterilization cycles
Water consumption will depend on the time between sterilization cycles. If the distilled or demineralized water in the storage tanks remains warm as a result of continuous sterilization, the steam emitted from
the sterilization chamber will not completely con­dense. Part of this steam will escape from the stor­age tank.
Cooling coils
If a long time has passed since distilled or deminer­alized water has been refilled, and if the water level in the storage tank has dropped below the cooling coils, the emitted steam will also not fully condense, and will escape.
4.2.2 Refilling with fresh water _______________________________________________
Dirty water in the storage tank
The water in the storage tank will become quickly dirty if the instruments are not carefully cleaned be­fore each sterilization process. You must regularly check the water in the storage tank for cleanliness. If the water is dirty and murky, or if there is a surface film on the water, or if there
is a coating on the bottom and walls of the tank, then you must by all means replace the distilled or de­mineralized water in the tank. If there are greasy deposits in the tank, we recommend filling the stor­age tank with warm water containing a grease cutter (the German product Pril or an equivalent), and cleaning out the tank with a bottle brush. Then rinse out with fresh water (for water quality, see Section
4.2 above).
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Operating Manual for MELAtronic®17/23
4.2.3 Emptying the water storage tank _________________________________________
You can drain out dirty water from the storage tank by opening the drain (16) for distilled water (turn to the left), and allowing the dirty water to flow into a container. First, attach the supplied drain hose to the sleeve of the drain (16).
Close the drain by turning to the right, and fill the storage tank up to the “MAX” level with approx. three (3) litres of distilled or demineralized water.
5 Troubleshooting
The following instructions will help you to correct minor malfunctions. They will also help you to give an exact description of more serious trouble to your
specialist MELAG dealer, your MELAG depot, or the MELAG Customer Service representative.
5.1 Trouble without an error report ____________________________________________
5.1.1 No display ____________________________________________________________
If you switch on the power to the autoclave, and if nothing appears in the display, then check the fol­lowing:
1. Check to make sure that the power cable is prop­erly plugged into the power socket.
2. Check to see if there power at the socket.
3. Check the fuses at the rear of the autoclave. If
they have blown, replace them. Danger: Before opening the fuse mounts, unplug the power ca­ble. Replace with the spare fuses on the rear wall of the autoclave
5.1.2 No pressure display / Low reading on the pressure gauge _________________
If, after a sterilization cycle, the red non-return (slave) pointer does not show at least the pressure required for the selected program, and if there is no error message on the display, then the pressure gauge or the red pointer of the gauge are probably
defective. If so, the pressure gauge must be re­placed. If you replace the pressure gauge, and if the pres­sure indication is still too low, then the trouble is in the temperature-control system (temperature sensor / electronic controller).
5.1.3 High reading on the pressure gauge ______________________________________
The red non-return pointer jams (fails to move)
It is possible that the red non-return will jam (stick), and will fail to move. This may be caused if the white pointer will try to drag along the “jammed” red pointer, and if the pressure is great enough to “knock away” the red pointer. The red pointer will then not stand at the maximum pressure reached in the sterilization, but will remain at the point where the white pointer has knocked it. This means that the red pointer will show a pressure that the autoclave has not reached in its cycle (for example, 4.5 bar). In such a case, you can check to see the actual pres­sure achieved in the autoclave by standing in front of the autoclave and watching the white pointer during a sterilization cycle.
Insufficient ventilation
If the pressure gauge shows a pressure that is con­siderably higher than 1.3 bar for Program 1, or higher than 2.4 bar for Program 2, then you must check the ventilation functions of the autoclave. Check as follows:
1. Check to see if the feed-water filter in the sterili­zation chamber is dirty.
2. Check to see if the vent nozzle in the water storage tank is stopped up.
3. Check to see if the solenoid valve for pressure release opens during the ventilation phase.
If these checks show that the ventilation process is OK, and if the pressure on the gauge is still too high, then the pressure gauge or the electronic tempera­ture-control is defective.
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5.1.4 Poor drying ___________________________________________________________
Cause: you have not loaded the autoclave cor­rectly
Do not load the autoclave with more items than the maximum specified amount. Be sure to arrange the items on the trays so that the condensation can properly run off.
Cause: you have not left the door slightly open
To achieve good drying, you must leave the auto­clave door slightly open at the end of sterilization.
Cause: too much water remains in the steriliza­tion chamber
It is not possible to avoid leaving a small amount of water in the sterilization chamber after the cycle. When the autoclave cools, the residual steam (no longer under pressure) will condense on those sur­faces that cool off first: the door and the bottom of the chamber. The water will then collect at the bot­tom of the chamber. The following can cause ex­cessive water to collect:
The filter of the sterilization chamber is dirty.
The solenoid valve that controls the water feed
leaks.
Cause: leak in the solenoid valve for water feed
If the instruments are not properly cleaned before sterilization, small particles of debris can cause the solenoid valve for water feed to slightly leak. The autoclave may still be able to reach the required pressure, but water may drip from the water tank into the sterilization chamber after sterilization. The problem here is not actually too much residual water. Check for a valve leak as follows: Take out the tray rack and wipe completely dry the inside of the sterilization chamber. After a few hours, the chamber should still be completely dry. If the cham­ber is wet, clean out the solenoid valve by blowing it with air.
5.1.5 Overheating __________________________________________________________
Overheating is almost always caused by too little water in the sterilization chamber. If the autoclave overheats:
Switch off the autoclave
Open the door and allow the autoclave to cool
down for 30 min
Before putting the autoclave back into operation, check for the following possible causes:
Loading
When textiles are sterilized, they absorb a great amount of steam and water. For this reason, never put more textiles in the autoclave than allowed. Never operate the autoclave without the tray rack.
Vent nozzle
If instruments are not properly cleaned before sterili­zation, particles of debris will enter the distilled or demineralized water and, in turn, the steam. If the
autoclave is then used frequently for long periods of time, these particles together with the long and in­tensive action of the debris in the flowing air and steam will cause the vent nozzle to “wash out”. This means that the vent opening will be enlarged, and that excessive steam will be lost. In such a case, the vent nozzle must be exchanged.
Solenoid valves
If the instruments are not properly cleaned prior to sterilization, debris will enter the solenoid valves for water feed and for quick pressure release, and will cause them to leak.
Safety valve
The safety valve is located in the water storage tank, below the upper part of the U-shaped bow of the “MAX” water-level mark. If this safety valve trips at pressure-gauge readings of less than 2.5 bar of steam, then it must be replaced.
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5.1.6 Malfunctions with error messages ________________________________________
If any of the following error messages appear, you must first acknowledge the message by pressing the button to show remaining run time / cancel error message (11), located below the display. After the
cause of the error has been eliminated (operator fault or technical defect), then you must start the program again.
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Operating Manual for MELAtronic®17/23
5.1.7 The error message “Err1” _______________________________________________
This error message means that the monitored time for the heating-up phase has exceeded its limit. Check for one of the following possible causes if “Err1” appears:
Too many items have been loaded
Make sure by all means that you do not load more than the maximum amount allowed in these instruc­tions.
Water-feed switch was not activated
The water feed switch was not activated, or it was not switched off after a sufficient amount of water has entered the sterilization chamber.
The door is not tightly sealed
Close the door tightly. If necessary replace the door seal (gasket).
The vent nozzle is “washed out”
If the orifice of the vent nozzle has become washed out, it will be too large for the autoclave to reach the required pressure. In such a case, replace the noz­zle.
Leaks in the valves
The solenoid valves for water feed and for quick pressure release may be clogged and leaky. The pressure-release valve may also have a leak. See
The overheating protection function has tripped
Check the position of the jacket heating unit. This unit should be pushed as far in as it can go at the bottom rear fitting of the sterilization chamber.
The heating system is defective
An electrical check of the heating system is neces­sary.
5.1.8 The error message “Err2” _______________________________________________
You have aborted the running program
The error message “Err2” will appear after a pro­gram has been started, and if the user then presses the button to turn the drying function off (10 and the button for program selection (4).
Program selection
The error message “Err2” will appear if you start one program, and then use the switch for program selec­tion (4) to choose another program.
The power has failed
The error message “Err2” will appear if you start a program, and if the power to the autoclave fails (i.e., if the building power fails, or if you switch off the autoclave by its power switch).
Temperature leaves required range
The error message “Err2” will appear if the actual temperature has left the range required for the se­lected program (temperature too high or too low).
5.1.9 Error message “1999” __________________________________________________
This message will appear if the temperature sensor is defective (the cable has broken, or there is a
short circuit).
6 Safety instructions / Warnings
Warning: After opening the autoclave door, do not
touch exposed hot metal parts. Use the MELAG Tray Handle to remove hot trays, and use suitable heat-protection gloves to remove other sterilization containers. Drain the water out of the water storage tank before transporting the autoclave. Do not tip the autoclave if there is water in its tank. Do not open the door of the autoclave until you are sure that there is no pressure inside. It is safe to
open the autoclave if the pressure gauge shows “0”. Danger: Small amounts of hot steam can escape the autoclave and burn users. These autoclaves may be repaired only by persons authorized by MELAG, and only with original MELAG spare parts. Danger: Never open the en­closure of the autoclave without first pulling the plug of the power cable. These autoclaves are not suited for sterilization of liquids.
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7 Placing the autoclave out of operation / Transport instructions / Placing the
autoclave back into operation
To place these autoclaves out of operation, and to transport them, observe the following:
Pull out the plug of the power cable. Allow the autoclave to cool down.
Drain the water out of the storage tank by opening the drain plug (16).
If you transport the autoclave while the tray racks and/or the trays themselves are still in­side, you must protect the polished door of the autoclave from being damaged. Place foam rubber between the racks or trays and
the door: or use some other suitable material such as Bubble Wrap
When you place the autoclave back into op­eration after moving or repairing it, follow the instructions given above in Section 2, “Placing the autoclave into operation”.
Important: To avoid damaging the autoclave during transport, be sure to use its original packaging.
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Operating Manual for MELAtronic®17/23
8 Annex / Spare parts
8.1 Spare parts ____________________________________________________________
Article no. Description of article
34125 Vent nozzle (with M6, SW 8 threads)
16005 Safety valve (officially calibrated)
32670 Door seal, for MELAtronic®17
34150 Door seal, for MELAtronic®23
34010 Filter for sterilization chamber
35496 Temperature sensor for steam
34165 Pressure gauge
58740 Overheating protection unit (installed on the sterilization chamber)
57592 Fuse: 16 A FF for models designed for 230 V operation
57590 Fuse: 20 A FF for models designed for 110 V operation
Operating manual MELAtronic 17-23.doc Revision 0 - 01/466 Page 15
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